(99 days)
Not Found
No
The 510(k) summary describes a mechanical implant (vertebral body replacement device) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The focus is on the material, design, and clinical performance of the physical device.
Yes
The device is intended to replace diseased or damaged vertebral bodies caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy, which are therapeutic interventions.
No
The device is described as a vertebral body replacement system, which is an implant used for surgical reconstruction, not for diagnosis.
No
The device description explicitly states the device is manufactured from Ti-6A1-4V ELI and is available in different shapes and sizes, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The NuVasive® X-Core® Mini Cervical Expandable VBR System is a physical implant made of titanium that is surgically placed in the cervical spine to replace damaged vertebral bodies.
- Intended Use: Its intended use is to provide structural support and stability in the spine, not to perform diagnostic tests on biological samples.
The provided information clearly describes a surgical implant used for structural support and reconstruction within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NuVasive® X-Core® Mini Cervical Expandable VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive® X-Core® Mini Cervical Expandable VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The NuVasive® X-Core® Mini Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Product codes
PLR
Device Description
The X-Core® Mini Cervical Expandable VBR System is manufactured from Ti-6A1-4V ELI conforming to ASTM F136 and ISO 5832-3. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This 510(k) is to expand the indications for use of NuVasive® X-Core® Mini Expandable VBR System (K142205) to include treatment of tumors, trauma, and degenerative disorders of the cervical spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C3-C7 vertebral bodies)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Clinical performance data on the subject device, as well as clinical literature review and retrospective clinical data analysis was performed to support the use of the subject device for expanded indications for use. Based on the published clinical literature review and retrospective clinical data analysis, it was determined that the NuVasive® X-Core® Mini Cervical Expandable VBR System used in the treatment of tumors, trauma, and degenerative disorders of the cervical spine has a safety and effectiveness profile that is similar to the predicate device. No other changes have been made to the system design since its clearance in the NuVasive® X-Core® Expandable VBR System 510(k) K142205. Therefore, no new nonclinical testing was performed for the purpose of this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, overlapping to create a sense of unity and connection. The symbol is meant to represent the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2015
NuVasive, Incorporated Ms. Olga Lewis Lead Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K151651
Trade/Device Name: NuVasive® X-Core® Mini Cervical Expandable VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: PLR Dated: August 26, 2015 Received: August 27, 2015
Dear Ms. Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151651
Device Name
NuVasive® X-Core® Mini Cervical Expandable VBR System
Indications for Use (Describe)
The NuVasive® X-Core® Mini Cervical Expandable VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive® X-Core® Mini Cervical Expandable VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The NuVasive® X-Core® Mini Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font, with a horizontal line extending from the "S" in "Speed" to the end of the word "Innovation."
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR $807.92, the following summary of information is provided:
Submitted by: A.
Olga Lewis Lead Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: August 26, 2015
B. Device Name
| Trade or Proprietary Name: | NuVasive ® X-Core ® Mini Cervical Expandable VBR System |
|---|---|
| Common or Usual Name: | Spinal Vertebral Body Replacement Device |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3060 |
| Product Code: | PLR |
C. Predicate Devices
The subject NuVasive® X-Core® Mini Cervical Expandable VBR System is substantially equivalent to the primary predicate device NuVasive® X-Core® Expandable VBR System (K142205) and the additional predicate device, NuVasive® CoRoent® System (K081611).
D. Device Description
The X-Core® Mini Cervical Expandable VBR System is manufactured from Ti-6A1-4V ELI conforming to ASTM F136 and ISO 5832-3. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the This 510(k) is to expand the indications for use of NuVasive® X-Core® patient. Mini Expandable VBR System (K142205) to include treatment of tumors, trauma, and degenerative disorders of the cervical spine.
4
Indications for Use E.
The NuVasive® X-Core® Mini Cervical Expandable VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive® X-Core® Mini Cervical Expandable VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The NuVasive X-Core® Mini Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
F. Technological Characteristics
As was established in this submission, the subject NuVasive® X-Core® Mini Cervical Expandable VBR System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent based on clinical data and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, performance, material composition, and function.
G. Performance Data
The purpose of this 510(k) is to modify the Indications for Use for the subject NuVasive X-Core® Mini Cervical Expandable VBR System. Clinical performance data on the subject device, as well as clinical literature review and retrospective clinical data analysis was performed to support the use of the subject device for expanded indications for use. Based on the published clinical literature review and retrospective clinical data analysis, it was determined that the NuVasive® X-Core® Mini Cervical Expandable VBR System used in the treatment of tumors, trauma, and degenerative disorders of the cervical spine has a safety and effectiveness profile that is similar to the predicate device. No other changes have been made to the system design since its clearance in the NuVasive® X-Core® Expandable VBR System 510(k) K142205. Therefore, no new nonclinical testing was performed for the purpose of this submission.
H. Conclusions
Based on the indications for use, technological characteristics, mechanical testing, and comparison to predicate devices, the subject NuVasive® X-Core® Mini Cervical Expandable VBR System has been shown to be substantially equivalent to legally marketed predicate devices.